Overview

Belgium is an economically developed nation with due credit to its industrial progress and huge healthcare spends. Drug and biological products must be authorized by the Federal Agency for Medicines and Health Products before distribution and marketing for human use in Belgium. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:  

  • Article 8(3) for New Chemical Entity (NCE) 
  • Article 10 for generic, hybrid and similar biological medicinal products  

Further, the Market Authorization Holder (MAH) has to meet all the requirements listed out by the European Union (EU) and European Economic Area (EEA) considering the UK as a 3rd country post March 30, 2019.

The sub-optimal authorization may be of concern for pharmaceutical product sponsors slowing down the pace of approval. With its progressive industrial regime, Belgium also has tough regulations and immense scrutiny in place which may deter the manufacturers’ budget projections.

Freyr helps the applicants to navigate through tough Regulatory regime by keeping them abreast with Regulatory and market intelligence. Freyr experts ensure successful submissions with right-first-time approach by handling dossiers and other pre-submission deliverables as per Federal Agency and EU regulations. Freyr also maintains product compliance on behalf of sponsors in long-term by extending post-approval support for various activities.

 

Freyr Expertise 

  • Initial submissions (MAAs) via various procedures- National, Mutual Recognition Procedure (MRP), Decentralized Procedure (DCP) and Centralized Procedure (CP) for innovator, hybrid and generic products 
  • Regulatory consultation and strategic support on submission roadmaps, and procedures 
  • Pre-submission administrative activities such as interaction with Health Authorities (HAs), slot booking for submissions, selection of the RMS and CMS, request to HA to work as RMS 
  • Evaluation of the product and source data from R&D and manufacturing site (executed data) for the EU-specific Regulatory and submission requirements 
  • Compilation and submission of the dossiers to HAs in eCTD format as per Federal Agency for Medicines and Health Products requirements 
  • Consultation during developments and manufacturing of the medicinal products 
  • Initial submissions for APIs - ASMF/ CEP submissions  
  • Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV) in EU 
  • Post-approval change submissions with strategies and compilation/ submission for:   
    • MAH transfers 
    • Post-approval quality change like-  
      • Change in manufacturing site, addition/deletion of the site, Batch size change, changes in manufacturing changes, administrative and labeling changes 
    • Monograph updates i.e. compliance to European pharmacopoeia 
    • Changes in container closure system 
    • Change in primary packaging material supplier 
    • Shelf life extension/reduction 
    • Addition of new supplier for active substance 
    • Inclusion of additional source for starting material for drug substance 
  • Impact analysis of Brexit and submission of the relevant changes to HA(s) like- change in Reference Member State (RMS), changes to MAH, addition/ replacement of the batch release and testing sites, changes to the QP, QPPV and Pharmacovigilance system master file (PSMF) (Article 57 notification) 
  • Life cycle maintenance by submission of renewal applications 
  • Support in handling deficiencies with Regulatory strategy and preparation and submission of the response